NCT05240612

CompletedPhase 1

A Clinical Pharmacological Study of MT-3921 in Subjects With...

Tanabe Pharma Corporation Source

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Other study identifiers

Sponsor study identifier

MT-3921-C-101

Secondary identifiers

jRCT2031210616

REGISTRY · Japan Registry of Clinical Trials (jRCT)

Study Type

interventional

Actual enrollment (reported)

15

Locations

1 country

Sites

1

Timeline

Study Start

May 2, 2022

Actual (reported)

Primary Completion

September 14, 2023

Actual (reported)

Study Completion

December 28, 2023

Actual (reported)

Brief Summary

The purposes of this study is to assess the safety, tolerability, and pharmacokinetics of MT-3921 in subjects with Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy(HAM). Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 15 participants
Study completion date: December 28, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 13, 2022
Actual (reported)
First Posted
February 15, 2022
Actual (reported)
Study Start
May 2, 2022
Actual (reported)
Primary Completion
September 14, 2023
Actual (reported)
Study Completion
December 28, 2023
Actual (reported)

Last Updated: January 29, 2024
Status Verified: January 2024
Last Update Submitted: January 25, 2024

Conditions

HTLV-1-Associated Myelopathy (HAM)

Outcome Measures

Primary Outcomes (4)

Percentage of subjects with adverse events
36 weeks
Percentage of subjects with adverse reactions
36 weeks
Serum concentrations of MT-3921
PK samples will be collected at predose, 1.5 hours, 2, 4, 8, 12, 20 (predose and 1.5 hours), 24, 36 weeks post-dose.
CSF concentrations of MT-3921
PK samples will be collected at 2, 4, 12, 24 weeks post-dose.

Study Arms (2)

MT-3921

EXPERIMENTAL

Intravenous (IV)

Biological: MT-3921

Placebo

PLACEBO COMPARATOR

Intravenous (IV)

Biological: Placebo

Interventions

MT-3921Biological

Solution for infusion; Intravenous (IV)

Also known as: Unasnemab

MT-3921

PlaceboBiological

Solution for infusion; Intravenous (IV)

Placebo

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Additional screening criteria check may apply for qualification:
Subjects aged 20 years or older on the day of consent

Sponsors & Collaborators

Tanabe Pharma Corporation
Industrylead

Study Sites (1)

St. Marianna University Hospital

Kawasaki-shi, Kanagawa, 216-8511, Japan

MeSH Terms

Conditions

Paraparesis, Tropical Spastic

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsHTLV-I InfectionsDeltaretrovirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory Diseases

Study Officials

General Manager
Tanabe Pharma Corporation
STUDY DIRECTOR

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 13, 2022

First Posted

February 15, 2022

Study Start

May 2, 2022

Actual (reported)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Subjects with a confirmed diagnosis of HAM according to the diagnostic algorithm of Practical Guideline for HAM 2019 on the day of consent

Subjects with an Osame's motor disability score (OMDS) of ≥4 and ≤6 at Screening and on the first day of the Treatment period (predose)

Subjects with no change in OMDS for at least 3 months before the day of consent

Subjects with a CSF concentration neopterin of ≥6 pmol/mL at Screening

Subjects on maintenance oral steroid therapy who have continued to receive the same dose equivalent to ≤10 mg/day of prednisolone for at least 3 months before the day of consent

You may not qualify if:

Additional screening criteria check may apply for qualification:
Subjects who have a history of anaphylaxis or clinically significant allergic reactions due to administration of antibody products
Subjects exhibiting or with a history of malignant tumor.
Subjects with adult T-cell leukemia/lymphoma (ATL) or those with positive HTLV-1 clonality test (Southern blot) at screening and suspected of having ATL
Subjects with spinal cord compression lesions, such as cervical spine disease, disc herniation, and ossification of the yellow ligament
Subjects with psychiatric disorders, epileptic seizures, or dementia.
Subjects with suicide attempts or suicidal ideation corresponding to item 4 or 5 on the Columbia Suicide Rating Scale (C-SSRS) at screening and/or on the first day of the Treatment period (predose)
Subjects exhibiting or with a history of hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection.
Subjects with the novel Coronavirus disease 2019 (COVID-19)
Subjects with severe illness
Male or female subjects of childbearing potential who do not agree to use a contraceptive measure from the day of consent to 16 weeks after the last dose of the investigational medical product
Female subjects who are pregnant, lactating, or may be pregnant
Subjects who have received anti-repulsive guidance molecule (RGM) a antibody containing this investigational medical product
Subjects who participated in other clinical studies (including clinical trials) and received drugs (including investigational medical products) or therapy within 12 weeks before the day of consent

Contact the study team to confirm eligibility.

Primary Completion

September 14, 2023

Actual (reported)

Study Completion

December 28, 2023

Actual (reported)

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05240612
Data provider: ClinicalTrials.gov
Source updated: 2024-01-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:19 UTC

Locations

JP(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

MT-3921

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations